FDA 510(k)

BioGuard 空氣/水及吸引閥

K 號：K203630 · 2021-01-08

決定日期2021-01-08

產品代碼ODC

諮詢委員會GU

決定相當於

器材摘要

BioGuard Air/Water and Suction Valves is the device name listed in this FDA 510(k) record. The listed applicant is Steris Corporations. It received FDA 510(k) clearance on 2021-01-08 under 510(k) number K203630. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BioGuard Air/Water and Suction Valves?

BioGuard Air/Water and Suction Valves is a medical device that received FDA 510(k) clearance on 2021-01-08. The listed applicant is Steris Corporations. The 510(k) number is K203630.

When did BioGuard Air/Water and Suction Valves receive FDA 510(k) clearance?

BioGuard Air/Water and Suction Valves received FDA 510(k) clearance on 2021-01-08, under 510(k) number K203630.

Who is the listed applicant for BioGuard Air/Water and Suction Valves?

The FDA 510(k) record lists Steris Corporations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioGuard Air/Water and Suction Valves?

The FDA product code for BioGuard Air/Water and Suction Valves is ODC.

其他以 Steris Corporations 為申請人之記錄

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相關器械（代碼：ODC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252933DYNE PORTDyne Medical Group, Inc.K250145組織切片端口轉接器Endosound, Inc.K252910Orca 空氣/水及吸引閥Boston Scientific K250949吸引閥 (MAJ-1443)；空氣/水閥 (MAJ-1444)Olympus Medical Systems Corporation K250732一次性內視鏡閥門組Yangzhou Fartley Medical Instrument Technology Co., Ltd.K241842路氏分離 MAJ-2092Olympus Medical Systems Corporation

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